Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training

Summary

Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles. In this operation, the subpulmonary ventricle is bypassed, connecting the systemic veins directly to the pulmonary arteries. The lack of a subpulmonary ventricle is associated with a nonpulsatile pulmonary flow and triggers a sequence of adaptive mechanisms along the life of these patients. The most frequent consequence of these adaptative mechanisms is the reduction in functional capacity, objectively measured by the decrease in peak oxygen consumption (VO2). So, cardiovascular and pulmonary functioning and skeletal muscle alterations can explain exercise intolerance in these patients.

Objectives: 1. To compare the cardiovascular, pulmonary, and musculoskeletal system variables in clinically stable Fontan patients with Healthy subjects; 2. To correlate the variables of the cardiovascular, pulmonary, and skeletal muscle with the functional capacity in Fontan patients; 3. To identify predictors of low functional capacity in this population; 4. To evaluate four-month aerobic exercise and inspiratory muscle training on functional capacity, pulmonary function, and autonomic control in patients after Fontan operation and compare to the group with no exercise training.

Methods: All subjects were submitted to cardiovascular, pulmonary, and skeletal muscle evaluation at baseline to perform a cross-sectional study comparing Fontan Patients (FP) with Healthy Controls (HC). In addition, the FP accepted to participate in the longitudinal clinical trial to evaluate exercise programs were randomized into three groups: Aerobic Exercise Training (AET), Inspiratory Muscle Training (IMT), and Non-exercise Training Group (NET, a control group). All patient groups (AET, IMT, NET) were reassessed after four months of training or under usual care.

Expected Outcomes: This study expects to demonstrate that impaired pulmonary function, altered neurovascular control, and reduced skeletal muscle could be an additional potential mechanism for reducing functional capacity in clinically stable Fontan patients. And this impairment could be diminished by exercise training, enhancing physical capacity, and exercise tolerance.

Conditions

• Congenital Heart Disease
• Single Ventricle
• Univentricular Heart

Interventions

OTHER

Aerobic Exercise Training

Supervised aerobic and light muscle resistance exercise training

OTHER

Inspiratory Muscle Training

Inspiratory muscle training with POWERbreathe device

OTHER

No Exercise Training

Usual care

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Marcelo B Jatene, MD,PhD · Heart Institute, University of Sao Paulo, Medical School

• Aida LR Turquetto, PhD student · Heart Institute, University of Sao Paulo, Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2016-01-30

Completion

2020-10-30

Countries

• Brazil

Study Locations